Phase 2 N=19 Treatment

Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

Kidney Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00331409 ↗

Enrolled (actual)

Serious AEs

52.6%

Results posted

Oct 2011

Primary outcome: Primary: Progression-free Survival at 3 Months — 2.9 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Everolimus (Drug); imatinib mesylate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: OHSU Knight Cancer Institute
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival at 3 Months	2.9	—
PRIMARY Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months	18	—
SECONDARY Median Time to Progression	2.9	—
SECONDARY Number of Subjects That Demonstrated a Reduction in Tumor Measurements.	5	—
SECONDARY Number of Participants With Adverse Events	19	—

Summary

RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria:
Measurable metastatic disease
Locally unresectable disease
No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery
Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 8 g/dL
Bilirubin 25% of bone marrow
No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor
No concurrent therapeutic warfarin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00331409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.